Medical device with slotted memory metal tube

ABSTRACT

A series of medical instruments can be made with the use of shape memory tube with a transformation temperature that is above or below the ambient temperature. In the first case, the material behaves with the shape memory effect and in the second case the behavior is superelastic. The wall of the tube has been provided with a plurality of slots in specific places, often near or at the distal end of the instrument, and in specific arrangements which allow local variations in diameter, shape, and/or length. These variations can either be caused by the memory effect during temperature change or by superelastic behavior during change of the mechanical influences on the memory metal by the surrounding material.

The present application is a continuation of U.S. Ser. No. 11/381,217,filed May 2, 2006, now issued as U.S. Pat. No. 8,052,670, which is acontinuation of U.S. Ser. No, 10/923,918, filed Aug. 23, 2004, nowissued as U.S. Pat. No. 7,037,321, which is a continuation of U.S. Ser.No. 09/156,276, filed Sep. 17, 1998, now issued as U.S. Pat. No.6,780,175, which is a continuation of U.S. Ser. No. 08/804,018, filedFeb. 21, 1997, now issued as U.S. Pat. No. 5,885,258, which claims thefiling benefit of U.S. Provisional Application No. 60/012,220, filedFeb. 23, 1996, each disclosure of which is expressly incorporated hereinby reference in its entirety.

FIELD OF THE INVENTION

This invention generally relates to an instrument which uses a slottedmemory metal tube to perform or assist in various medical procedures.

BACKGROUND INFORMATION

Surgical and other medical procedures are often performed at siteswithin a patient's body. In the past, the only way to perform suchmedical procedures was to cut a large enough incision in the patient'sbody to expose the operating site sufficiently to permit direct accessby a physician. Such operations, however, typically caused a great dealof trauma to the affected tissue requiring lengthy periods for recoveryand causing the patient substantial pain and suffering. Withtechnological advances in the medical profession, more and more of theseprocedures are being performed using less invasive endoscopic andsimilar procedures. In general, endoscopic procedures include using aninstrument having a delivery tube with an inner bore through which atool can be inserted. With such an instrument, the delivery tube isusually inserted into the patient's body by way of either acomparatively small incision or a body orifice and through a body cavityor hollow organ to the site desired. In this way, any trauma to thepatient's body can be generally limited to surrounding tissue along theinsertion path of the delivery tube.

Many procedures have been limited to traditional direct access methodsdue to the size and method of operation of the tools used to perform theprocedures. As a result, there is a need for tools which are moreadaptable to use with endoscopic and similar procedures.

OBJECTS OF THE INVENTION

One object of the invention is a medical instrument with slotted memorymetal tube.

Another object of the invention is a retrieval basket for smallparticles.

A further object of the invention is a tool for dilating vessels andother tubular structures.

Yet another object of the invention is a device for reaming vascular,other tubular structures, or different shaped cavities.

Still a further object of the invention is a pump for injection of adefined quantity of fluid.

Yet a further object of the invention is an optical system with anexpanding section which allows inspection of the expanded area.

Another object of the invention is an internal gripper for holding softtissue such as skin, nerves, arteries, or the like or for holding clips.

Yet a further object of the invention is an external gripper forattaching to stems, tissue, or skin.

Still a further object of the invention is a tool for expanding cavitiesfor inspection.

A further object of the invention is an expandable plug for closing acavity or tubular structure.

Yet another object of the invention is a device for measuring thediameter of tubular structures.

Another object of the invention is a steerable catheter tip.

Still another object of the invention is a reinforced stent.

Additional objects, advantages, and novel features of the invention willbe set forth in part in the description which follows, and in part willbecome apparent to those skilled in the art upon examination of thefollowing description.

SUMMARY OF THE INVENTION

According to the present invention, the foregoing and other objects areattained by a medical instrument with slotted memory metal tube. Aseries of medical instruments can be made with the use of a shape memorytube with a transformation temperature that is above or below theambient temperature. In the first case, the material behaves with theshape memory effect, and in the second case, the behavior issuperelastic. Thus, the memory metal tube of the medical instrument isprogrammed for an effect selected from the group of effects consistingof memory effect and superelasticity.

In all of the disclosed types of instruments, the wall of the tube hasbeen provided with a plurality of slots in specific places, often nearor at the distal end of the instrument, and in specific arrangements,which allow local variations in diameter, shape, and/or length. Thesevariations can either be caused by the memory effect during temperaturechange or by superelastic behavior during change of the mechanicalinfluences on the memory metal by the surrounding material. Onepossibility to activate the superelastic shape change can be the use ofa second tube, surrounding the memory metal tube, sliding more or lessover the area where the slots in the memory metal tube are placed. Thesecond tube is used to control the final shape and it prevents shapechanges at undesired moments, such as during the procedure of insertioninto the human body. The delivery tube can be pulled backward over thecentral memory metal tube. As soon as the memory metal tube comes free,it can regain its preprogrammed shape whether by superelasticity or bytemperature change.

Dependent on the intended function of the device, the amount and patternof slots in the wall of the memory metal tube can be chosen. The slotscan be made by a variety of methods, such as, but not limited to,etching, spark erosion, water jet cutting, abrasive water jet cutting,laser cutting, or any mechanical means. An expansion of the slotted partof the desired programmed shape can be achieved by some internal orexternal mechanical means and, when the final heat treatment has beenapplied, the prestrained shape will be the new programmed shape. Afterremoving the internal or external shaping tool, the memory metal tube isready for use.

It is possible to make memory metal tubes which are deformed to a smalldiameter and which will return to a larger diameter in the slottedsection by superelasticity or by shape memory effect. The reverse isalso possible when the slotted section is opened to a larger diameterthan the programmed diameter by some internal restraining means. It willreturn to a smaller diameter when it is released. The slotted sectioncan be made in several places along the length of the memory metal tubeand the programmed shapes can vary over the length of the tube.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are pictorial views of a retrieval basket of the presentinvention.

FIGS. 1C and 1D are cross-sectional views taken along lines 1C-1C and1D-1D of FIGS. 1A and 1B, respectively.

FIG. 2 is a partial sectional pictorial view of a dilation tool of thepresent invention.

FIG. 3 is a pictorial view of a reamer of the present invention.

FIG. 4 is a pictorial view of a micropump of the present invention.

FIG. 5 is a partial sectional pictorial view of an optical system withexpander of the present invention.

FIGS. 6A and 6B are partial sectional pictorial views of an internalgripper of the present invention.

FIGS. 7A through 7D are partial sectional pictorial views of an externalgripper of the present invention.

FIG. 8 is a partial sectional pictorial view of an expander of thepresent invention.

FIGS. 9A through 9C are partial sectional pictorial views of anexpandable plug of the present invention.

FIGS. 10A through 10C are partial sectional pictorial views of ameasuring tip of the present invention.

FIG. 11 is a pictorial view of a steerable tip of the present invention.

FIGS. 12A and 12B are cross-sectional views of a reinforced stent of thepresent invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

A series of examples will describe certain preferred embodiments of thepresent invention.

Retrieval Basket

FIGS. 1A and 1B show a memory metal tube 11 with four slots 12 near thedistal end. The slots 12 create a balloon-shaped structure which can beused as a retrieval basket for small particles 14, with a closure aroundthe caught particle due to the concave shape of the inner wall of thememory metal tube 11. As shown in FIGS. 1A to 1D, particle 14 is a solidparticle. Dependent on the application, either the delivery tube 13 orthe memory metal tube is moved, but in both cases the relative axialmovement enables the expansion or the contraction of the memory metaltube. The single piece construction is far more simple than withconventional baskets made of several pieces that have to be connected.The advantage of the concave surface can be seen in the top views 1C and1D. In the case of activation by heat, the use of a delivery tool is notnecessarily required. With a warm liquid pumped into the memory metaltube, it can be activated (expanded) and with cold fluid it can bebrought into the martensitic, deformed state again (contracted).

Dilation Tool

FIG. 2 shows a tool for dilation of tubular structures such as vessels24 where the wall thickness of the capillary memory metal tube 21 andthe geometry of the segments 22 determine the dilation force F. Thedelivery tube 23 can be kept in place and the memory metal dilator withthe desired dilation force can be inserted. Several dilators withincreasing force can be inserted to gradually increase the innerdiameter of the artery or cavity. The memory metal tube can either beheated to increase the force and/or diameter, or it can be usedsuperelastically where the well defined plateau stresses give apredetermined and known force. Conventional dilation techniques use aseries of tools with increasing diameters, which work less efficientlyin many cases.

Reamer

FIG. 3 shows a reamer where the edges 32 of the slotted section havebeen sharpened. By relative axial movement of the memory metal tube 31and delivery tube 33, the diameter of the reamer is continuouslyvariable. By relative tangential movement (rotation) of the reamer inthe delivery tube, the sharp edges of the expanded section cut particlesof the inner wall of the artery or any other tubular or other shapedcavity.

Micropump

FIG. 4 shows a small micropump for the local injection of a well definedquantity of fluid. An example of such a fluid would be a dissolutionfluid for obstructions in arteries or kidney stones. The slotted section42 of the metal tube 41 creates a balloon shaped room 45 with a specificvolume. The slotted section 42 is expandable and either surrounds or issurrounded by an elastic material in the shape of a balloon. Two one wayvalves 46 and 47 above and below the balloon section and connected toits distal and proximal ends, respectively, enable a pumping action inthe distal direction by advancing the delivery tube 43 over the slottedsection 42 of metal tube 41. This decreases the volume. Both valves areopening in the same direction and by moving in and out (as shown by thearrows) the balloon pump and deliver one shot of liquid repeatedly.

Optical System with Expander

FIG. 5 shows a memory metal tube 51 with an expanding section 52 thatcan contain an optical fiber 56 in the center, with the free end of thefiber in the center of the expanding section 52, thus enabling aninspection of this expanded area and adjacent areas. The ratio betweenconstrained and expanded diameter can be very large (e.g., a factor of10), which makes it possible to inspect cavities that are more or lesscollapsed or deformed. The inner wall of the expanded cavity can beobserved as well as the area in front of the tip as shown by themultidirectional arrows. This tool can be used for gynealogics, urethra,ear, nose, arteries, biliaric, esophageal inspections in cavities and/orcylindrical rooms, etc. Another feature of this device is the exactfixation of the inspection fiber(s) in the center of the cavity. Adelivery tube 53 can also be utilized to control the expansion of theexpanding section 52.

Internal Gripper

FIG. 6A shows a memory metal tube 61 with slots 65 that proceed to thedistal end of the tube. The tube end has been programmed into a grippershape for holding soft tissue like skin, nerves, arteries, clips, etc.When the delivery tube 63 is pushed forward the curved tube segments 62close toward the center axis of the instrument. In the case of use withclips, a double hook such as that shown in FIG. 6B is used to hold asurgical memory metal clip 67, bring it over the artery 68, fallopiantube, oviduct, or nerve that has to be held by the clip, heat the clipto close it over the artery by means of a warm fluid inserted throughthe memory metal tube. After closing of the clip, the delivery tube 63is moved back to open the hooks again, leaving the clip where it is.Then the gripper is closed again and the tool is pulled back.

External Gripper

Similar to the previous example of an internal gripper, FIGS. 7A and 7Bshow an external gripper in which the slots 77 proceed to the free endof the memory metal tube 71. Now the curved segments 72 have beenprogrammed to curve into an outward direction. FIG. 7A shows a gripperthat can catch a lost or migrated stent from the inside to move it in alongitudinal direction. FIG. 7B shows a gripper with segments 72 thatare programmed to make a closed loop against the outside wall of thedelivery tube 73. When the tip of each section is sharpened, thesesections can cut themselves a path through soft tissue. This enables theuse as a connector, that holds itself tightly to the soft tissue,because of its geometry. Such a connector can be the tip of a pacemakerlead or an electrode for measuring or electrical stimulation, e.g., forpotential measurements in the inner wall of the stomach. FIG. 7C givesan example of a conventional skin hook that holds a wound open duringsurgery. Sometimes these skin hooks fall off. Superelastic skin hooksusing a closed loop 72 do not fall off so quickly, because they lock theskin completely in their closed loop. In this construction, as seen inFIG. 7D, the delivery tube 73 can have the shape of a hollow needle witha sharp point. Eventually a weight 78 is attached to the opposite endfrom the loop 72 to keep the skin 79 open.

Expander

An expansion tool, shown in FIG. 8, is used for difficult accessiblecavities where optical information is needed or where a place isrequired for working with instruments. As contrasted with the expandershown in FIGS. 2 and 5, here the expanding area is at the distal tip 82of the memory metal tube 81. The expander has a working canal 84 withdiameter D₁, to enable bringing instruments into the narrow cavity,which now has an expanded area 87. The cavity wall 89 is expanded by thetool from its normal diameter C₁ to an expanded diameter C₂ to createthe expanded area 87.

Expandable Plug

FIGS. 9A and 9B show a short length of memory metal tube 91 with aslotted section 92 that can be brought into a fallopian tube or oviduct97 in case of sterilization or any other cavity that is to be closed,either temporarily or permanently. This is done via a delivery catheter93. When the plug 94 (or sterilization device) is pushed from thedelivery catheter 93 into the cavity (such as fallopian tube 97), itwill expand and seal the cavity. This is achieved by the combination ofthe expanded slotted section 92 of plug 94 with an elastic polymer 95that fills the slotted section 92 in the plug 94. This elastic materialhas to be able to completely follow the deformation of the plug 94 fromcollapsed to final size. Eventually, the plug 94 can be filled with aUV-curing material to make it solid by means of a light from a corefiber. At the proximal end of the plug 94, an extraction wire 96 (orhook or eyelet) is provided for withdrawal into delivery tube 93 in casethe plug has to be removed again. FIG. 9C shows a chalice-shaped variantof a sterilization device 94 with a slotted tube 150 that has slots atboth ends to make a device that can be put into a cavity that has ashape with a smaller diameter in the center area and bigger diametersabove and below (i.e., a cavity with a constricted portion). This is thecase in the exit side of the oviduct, near the uterus. The center areaof the hollow memory metal tube 150 is sealed with a plug 99 having anattached extraction wire 96. The expanded sections 151 and 152 of tube150 can be combined with an elastic polymer (not shown) that finishesthe chalice shape to result in less irritation of the adjacent tissueand to get a better sealing against the wall of the oviduct 97.

Measuring Tip

The reamer of FIG. 3 or the expander of FIGS. 2 and 5 can also becombined with an optical or mechanical means to measure the diameter ofthe cavity at any position near the distal end of the tube, such as anartery wall 10. This can be achieved in several ways. FIG. 10A shows amemory metal tube 101 with an expanding section 102 and a delivery tube103. The memory metal tube 101 itself acts as a delivery tube for athird tube 107 that contains an optical system 106 that looks forwardfrom the distal tip 109 for visual inspection (as represented generallyby the arrows), and provides a light image.

An alternative embodiment is shown in FIG. 10B where the memory metaltube 101 holds a delivery tube 107 with a superelastic measuring wire108 in the center thereof, that has been programmed to make a curvatureat the tip when it leaves the restraining tube 107. With a scale readoutat the proximal side of the catheter/endoscope, the radius of the cavityat the measuring spot can be seen by determining the moment that thebending tip touches the inner wall.

In FIG. 10C, a third variant is shown with a hollow superelastic wire108 that has been programmed in the same way as described above withrespect to FIG. 10B. In this embodiment, the hollow wire 108 contains anoptical system 111, thus combining the optical readout with a bendingtip. This improves the accuracy, because the light emitter/sensor 109comes closer to the wall than in the situation described under FIG. 10A.

Steerable Tip

A steerable catheter tip can be made by means of a slotted memory metaltube, where the slots are made in such a way that a contraction orexpansion of a part of the wall can be achieved by local temperaturechanges. There are many options for the shape of expanding orcontracting sections. Pure bending of one or more segments of the wallcan also be used to make the tip steerable. In FIG. 11, one example isgiven of a memory metal tube 201 with slots 202 in a zigzag pattern toenlarge the possible contraction per segment 203, when it is heated togive an angular deviation of the top portion 204 compared to the centralaxis of the lower portion of the memory metal tube 201. Heating can alsobe achieved in several ways, such as local light from a light source orresistance heating. The latter can either be indirect by heating aresistance film that is attached to the memory segment 202, or by directresistance heating of the memory metal. In the latter case, the segment202 must at least at one end be electrically isolated from the rest ofthe memory metal tube. This can be done by letting the zigzag slots runto the free end of the distal tip (not shown), where the electricalleads can be connected to the end of any single segment 202.

Reinforced Stent

A UV-curing polymer is used to make a stent very flexible duringinsertion and then let it solidify by light emission. A double-walledballoon with the UV curing polymer in-between is already on the market.However, in some cases, it would be an improvement to reinforce thistype of stent with an integrated memory metal stent based on theprinciple of a slotted memory metal tube to make the construction morestable. FIGS. 12A and 12B give a view of the cross section through acombined stent in collapsed and expanded shape, respectively. TheUV-curing balloon stent 303 is reinforced with segments 302 of a memorymetal tube. The slots in the memory metal tube are made in such apattern that the stent is expandable.

Although several embodiments of the present invention have beenillustrated in the accompanying drawings and described in the foregoingDescription of the Preferred Embodiments, it will be understood that theinvention is not limited to the embodiments disclosed but is capable ofnumerous rearrangements, modifications, and substitutions of parts andelements without departing from the spirit and scope of the invention.In some cases the tube can exist from several segments that run throughthe entire length from proximal to distal. This can be necessary ifthere has to be an electrical isolation between the expandable segments,like in the application of an electrode for measuring potential and/orelectrical stimulation of body parts.

The direction of the slots has been parallel to the longitudinal axis ofthe memory metal tube in the embodiments described above, but they canalso be cut into the wall in alternative directions to achieve betterperformance. An example would be a retrieval basket with helical shapedsegments. Further, it can be necessary to use more than one concentrictube with varying functions. Non-concentric tubes, which can be placedbeside one another, parallel in the delivery tube, are also embodimentsof the present invention.

1. A medical device for use within a tubular structure of a human body,the device comprising: at least one monolithic memory metal tubeconfigured and sized to be inserted within the tubular structure of thehuman body, the metal tube including at least one expandable sectionwith a plurality of metal members separated by openings, the pluralityof metal members being pre-programmed for a shape-memory effect based ona transformation temperature, the metal members expanding from acontracted shape to an expanded shape at or above the transformationtemperature to form a retrieval basket for retrieving particles to beremoved from the human body, each of the metal members beingsufficiently rigid to substantially maintain the expanded shape of theexpandable section when placed within and in contact with the tubularstructure of the human body, the expandable section being free ofinterior structure that is axially movable within the expandable sectionto expand and/or contract the expandable section, the metal tube havinga central longitudinal axis and a distal end, the expandable sectionbeing configured to catch a solid particle having a maximumcross-sectional dimension greater than a maximum cross-sectionaldimension of the distal end of the metal tube transverse to the centrallongitudinal axis of the metal tube.
 2. The device of claim 1, furthercomprising an outer tube surrounding the metal tube, the outer tubebeing slidable over the expandable section and configured to restrictthe expandable section to the contracted shape.
 3. The device of claim1, wherein the expanded shape is a shape programmed using the memoryeffect of the metal tube.
 4. The device of claim 3, wherein theprogramming of the shape is accomplished through a heat treatment of themetal tube.
 5. The device of claim 1, wherein the tubular structure ofthe human body is a blood vessel.
 6. The device of claim 1, wherein thetubular structure of the human body is a urethra.
 7. The device of claim1, wherein the metal tube has only a single lumen.
 8. The device ofclaim 1, wherein the metal tube has a proximal end and a longitudinalpassage with a central longitudinal axis coaxial to the centrallongitudinal axis of the metal tube.
 9. The device of claim 1, whereinthe openings are slots forming a slotted section, the slotted sectionbeing bounded by two non-slotted sections.
 10. The device of claim 1,wherein the openings each have a mid-longitudinal axis and a completeperimeter surrounding the mid-longitudinal axis.
 11. The device of claim1, wherein the plurality of metal members are deformed in a martensiticstate to the contracted shape.
 12. The device of claim 1, wherein themetal members remain in the contracted shape below the transformationtemperature independent of mechanical influences by any materialexternal to the metal members.
 13. The device of claim 1, wherein theplurality of metal members are activated by heat to form the expandedshape.
 14. The device of claim 1, wherein the plurality of metal membersare activated to form the expanded shape without the use of a deliverytool.
 15. The device of claim 14, wherein the delivery tool is an outertube.